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Recruiting NCT04790682

LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG

Trial Parameters

Condition Metastatic Lung Cancer
Sponsor Institut Curie
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-05-22
Completion 2029-06-03
Interventions
assessment of the predictive value of ctDNA level of the prominent mutant allele variation between baseline and week 6, on response to treatment according to RECIST 1.1 criteria.

Brief Summary

Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.

Eligibility Criteria

Inclusion Criteria: 1. Histologically-proven NSCLC. 2. Age ≥ 18 years. 3. Advanced or metastatic stage IV. 4. Treatment-naïve patient. 5. Eligibility to first-line treatment with immune checkpoint inhibitor. 6. Measurable disease according to RECIST 1.1 criteria on CT-Scan. 7. Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy. 8. No ALK or EGFR gene alteration. 9. Availability of tumor tissue for NGS analysis (7 slides). 10. PS 0 or 1. 11. Signed informed consent of the patient. Exclusion Criteria: 1. No social security affiliation. 2. Person under legal protection. 3. Pregnant and breastfeeding women. Patients can participate to another clinical trial that is not modifying immunotherapy or immunotherapy/chemotherapy treatment nor study follow-up ; after investigator's information

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